Access Pharma (OTC: ACCP): A Cancer Biotech Call Option Trade Print E-mail
Wednesday, 27 May 2009 09:35
The cancer biotech space has attracted the interest of investors, traders, and diversified healthcare giants this year with Johnson & Johnson (NYSE: JNJ) announcing a $1B cash tender offer for Cougar Biotech (NASDAQ: CGRB) last week and Roche's (VTX: ROG) (OTC: RHHBY) mega-deal to acquire full control of Genentech earlier this year. In addition, positive clinical trial results for Dendreon's (NASDAQ: DNDN) Provenge and stock price turnarounds from the brink of zero at Cell Therapeutics (NASDAQ: CTIC) have fueled interest in the small and micro-cap cancer bio-pharma space among investors and
traders looking for the next big trade.
Read more...
 
Hemispherx Biopharma Pays Exec Bonuses, Will Expand Efforts In Pandemic Influenza Initiatives Print E-mail
By M.E.Garza   
Wednesday, 27 May 2009 03:00
A few interesting news items today for everyone keeping watch on HemispherX Biopharma (Amex: HEB) as they await their FDA decision on approval of Ampligen(r) NDA for the treatment of Chronic Fatigue Syndrome. First, the Sage Group, a privately held international health care consulting group, announced today that HemispherX Biopharma has expanded the mandate for The Sage Group to include, in addition to the strategic partnering efforts related to Ampligen (an experimental immunotherapeutic) for Chronic Fatigue Syndrome, additional partnering efforts related to Ampligen's use to increase the effectiveness of preventative pandemic flu vaccines and the additional role of Alferon LDO (an experimental therapeutic) for treating various types of pandemic flu.
Read more...
 
FDA, Clinical Trial Updates: MAPP, CYTK, and HEB Post Big Gains Print E-mail
Tuesday, 26 May 2009 14:45
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.  
Read more...
 
Delays Keep Hemispherx (Amex: HEB) on Hold as FDA Staff Issues Come Into Play Print E-mail
By M.E.Garza   
Tuesday, 26 May 2009 08:34
Investors and CFS patients eagerly anticipating approval from the FDA on Hemispherx Biopharma's Ampligen may have to wait as much as 1-2 additional weeks for a decision according to the company's latest news release and

Error. Page cannot be displayed. Please contact your service provider for more details. (8)

Form 8K filing. Trading on Tuesday sent shares up over 25% and volume was up over 4 times the daily average on the news as investors interpreted the development as a positive sign that approval for the drug may be coming.
Read more...
 
US Health Department places first orders for development of H1n1 (Swine Flu) vaccine Print E-mail
By Staff and Wire Reports   
Tuesday, 26 May 2009 03:28
Flu shotThe U.S. Department of Health and Human Services announced it has placed a series of orders for more than $100 million each to several drug-makers asking for the development of an H1N1 flu vaccine. The move does not necessarily mean the government is going ahead with mass production of the vaccine. "The actions we are taking today will help us be prepared if a vaccine is needed," HHS Secretary Kathleen Sebelius said. Three major drug-makers have received vaccine orders so far.
Read more...
 
Extreme FDA Trades on Pending Medical Device Decisions Print E-mail
Monday, 25 May 2009 09:51
Below is a sample of extreme FDA trades on pending medical device decisions (510k or PMA filings) among companies with market caps below $150 million (M) which are taken from the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA does not issue PDUFA decision date deadlines for medical device applications, which consist of the 510(k) and pre-market notification application (PMA) routes. The review period for PMA filings is typically more involved and longer than 510(k) applications.
Read more...
 
Which Small Biotech Firms Could Reap Benefits From Government's Flu Vaccine Initiative? Print E-mail
By Peter DePalma   
Monday, 25 May 2009 03:00
Kathleen Sebelius(Updated 05/24/09) In news that could affect a number of publicly traded companies that hold U.S. licenses for flu vaccines (see list below), Health and Human Services Secretary Kathleen Sebelius announced that the department will take important steps necessary to prepare for potential commercial-scale production of a candidate vaccine for the novel Influenza A (H1N1). The Secretary is directing approximately $1 billion in existing funds that will be used for clinical studies that will take place over the summer and for commercial-scale production of two potential vaccine ingredients for the pre-pandemic influenza stockpile.
Read more...
 
FDA Calendar Update: Acusphere (OTC:ACUS), Cephalon (NASDAQ:CEPH) Print E-mail
Sunday, 24 May 2009 20:31
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.  
Read more...
 
Alzheimer’s discovery could bring early diagnosis, treatment closer Print E-mail
By Lauran Neergaard   
Saturday, 23 May 2009 12:54
There are more than 5.3 million people with Alzheimer’s in the United States, and more than 300,000 in Canada. Every one of those patients faces years of increasing mental incapacity followed by almost certain death, with no hope of treatment. The U.S. Alzheimer’s Association has called the current situation a “crisis.” Now, a discovery made by researchers at McGill University and the affiliated Lady Davis Research Institute for Medical Research at Montreal’s Jewish General Hospital offers new hope for the early diagnosis and treatment of Alzheimer’s disease.
Read more...
 
FDA, Clinical Trial Updates: GENZ, HGSI, LLY, NGSX Print E-mail
Thursday, 21 May 2009 16:14
Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.  
Read more...
 
<< Start < Prev 351 352 353 354 355 356 357 358 359 360 Next > End >>

Page 359 of 369
BMR:1